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510(k) Data Aggregation

    K Number
    K222921
    Device Name
    Minuteful-kidney test
    Manufacturer
    Healthy.io Ltd.
    Date Cleared
    2023-09-08

    (347 days)

    Product Code
    JIR, JFY, KQO
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
    Device Description
    The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device's kit includes a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.
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    K Number
    K210069
    Device Name
    Minuteful - kidney test
    Manufacturer
    Healthy.io Ltd.
    Date Cleared
    2022-07-06

    (541 days)

    Product Code
    JIR, JFY, KQO
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
    Device Description
    The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.
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    K Number
    K150330
    Device Name
    Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
    Manufacturer
    ACON Laboratories, Inc.
    Date Cleared
    2015-04-30

    (79 days)

    Product Code
    JIR, JFY
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mission Urinalysis Reagent strips (Microalbumin/Creatinine) are intended for the semi quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer. These measurements are used to assist diagnosis for kidney function. It is intended for professional use only at point-of-care locations.
    Device Description
    The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are firm plastic strips that contain two reagent areas to test for Microalbumin (low concentration of albumin) and creatinine in urine. Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) can be read by the Mission® U120 Urine Analyzer.
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    K Number
    K061419
    Device Name
    TECO MICROALBUMIN 2-1 COMBO STRIPS
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2007-01-26

    (249 days)

    Product Code
    JIR, JFY
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine. Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart. Teco Microalbumin 2-1 Combo Strips are recommended for use in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
    Device Description
    Teco Microalbumin 2-1 Combo Strips are designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine. The strips are read by visual comparing color chart.
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    K Number
    K022538
    Device Name
    IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
    Manufacturer
    DIAGNOSTIC CHEMICALS, LTD. (USA)
    Date Cleared
    2002-08-23

    (22 days)

    Product Code
    JIR
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For IN VITRO diagnostic use. There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but elevated urinary albumin levels, or microalbuminuria, refers to a level of the human protein albumin in urine above about 18 mg/L. Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifies samples as positive based on their being above or below a level of 18 mg/L. Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8); hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).
    Device Description
    Not Found
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    K Number
    K001810
    Device Name
    URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
    Manufacturer
    FLEXSITE DIAGNOSTICS, INC.
    Date Cleared
    2000-08-14

    (60 days)

    Product Code
    JIR
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994035
    Device Name
    IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2000-02-01

    (64 days)

    Product Code
    JIR
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImmunoDip™ Urinary Albumin Screen tests for the presence of elevated levels of albumin in urine. Elevated urinary albumin is also known as microalbuminuria. Elevated albumin is an early sign of possible kidney damage. Detection of elevated urinary albumin can aid in the early detection and monitoring of the course of incipient nephropathy in diabetics and hypertensive patients. For IN VITRO diagnostic use.
    Device Description
    ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip which is encased in a plastic housing. The ImmunoDip™ Urinary Albumin Screen is placed into a urine sample for at least three minutes and is then removed and read. Results are determined by visually comparing the relative color intensity of two blue bands to obtain a semi-quantitative result of Negative (<= 18 mg/L) or Positive (>18 mg/L). ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip containing monoclonal mouse antibodies against human serum albumin bound to colored latex beads. Human albumin is fixed in a band at the bottom half of the testing region. Goat anti-mouse antibodies are fixed in a band at the top half of the testing region. The dipstick is encased in an open-ended plastic housing. When the dipstick is placed into a urine sample cup, the urine sample migrates up the test strip. Albumin present in the urine binds with blue colored latex beads present in the strip. Both beads and albumin are carried up the device by capillary action. At low levels of albumin, the great majority of blue beads are bound at the lower band containing human albumin. At higher levels of albumin, many of the beads pass through the lower band and are bound at the upper band. Levels of albumin above the decision level value of 18 mg/L will produce color on the upper band which is darker than the lower band. By observing the appearance of the two lines, the user can semi-quantitatively determine the urine microalbumin concentration as either Negative (<=18 mg/L), or Positive (>18 mg/L).
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    K Number
    K992257
    Device Name
    NEW MULTIPLES REAGENT STRIPS
    Manufacturer
    BAYER CORP.
    Date Cleared
    1999-11-24

    (141 days)

    Product Code
    JIR, CDM, CEN, JFY, JIL, JIN, JIO, JJB, JMT, JRE, LJX
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips that contain reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein to creatinine ratio is also determined. The strips are read visually by comparison to a color chart on the bottle label. The "NEW MULTIPLES" Reagent Strips can also be read instrumentally on the CLINITEK®50, CLINITEK® 100, CLINITEK® 200+ and CLINITEK® 500 Urine Chemistry Analyzers. Bayer's "NEW MULTIPLES" Reagent Strips are intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism (e.g., diabetes mellitus), urinary tract infections and liver function. The strips also measure physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. Bayer's "NEW MULTIPLES" Reagent Strips are for professional use in Point -Of-Care locations such as physicians offices or clinics and centralized laboratory locations such as in hospitals.
    Device Description
    Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips for urinalysis that contain reagent areas for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, blood, glucose, ketone (acetoaceticacid), nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein-to-creatinine ratio is also determined. New Multiples Reagent Strips are manually dipped into a urine specimen and "read" visually using a color chart. "NEW MULTIPLES" Reagent Strips may also be read instrumentally, using the CIINITEK® family of Urine Chemistry Analyzers. The method is designed for use with random, overnight or timed specimens. Semi-quantitative results are available within one minute.
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    K Number
    K991315
    Device Name
    MICROALBUSTIX REAGENT STRIPS (OTC)
    Manufacturer
    BAYER CORP.
    Date Cleared
    1999-11-12

    (207 days)

    Product Code
    JIR, JFY
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MICROALBUSTIX Reagent Strips (OTC) are intended for home use by testing persons at risk for developing kidney damage MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria), creatinine in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read visually by comparing the color of the reacted strip to the color chart on the bottle label. MICROALBUSTIX Reagent Strips (OTC) provide semiquantitative results and are intended for home use by persons at risk of developing kidney disease.
    Device Description
    MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. MICROALBUSTIX Reagent Strips (OTC) are dipped into a urine specimen and "read" visually by comparing the color of the strip to a color chart on the label. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio can also be determined. Semi-quantitative results are available within one minute.
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    K Number
    K983774
    Device Name
    UALB
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1999-01-28

    (94 days)

    Product Code
    JIR
    Regulation Number
    862.1645
    Why did this record match?
    Product Code :

    JIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microalbumin assay is used for the quantitation of low levels of albumin in human urine. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques, the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
    Device Description
    Microalbumin is an in vitro diagnostic assay for the quantitative determination of low levels of albumin in human urine. Antibodies to albumin combine with albumin in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 340 and 700 nm, is directly proportional to the concentration of microalbumin in the sample.
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